Next generation of breast implants on horizon

Doctors, patients clamor, but safety critics abound

June 30, 2004|By Julia Sommerfeld, The Seattle Times.

SEATTLE — The quest for the perfect breast has come full circle. Even as checks from Dow Corning slip into mailboxes this month, finally settling thousands of silicone lawsuits, plastic surgeons and patients are clamoring for the latest breast-boosting technology--the next-generation silicone implant.

Now, U.S. women who want larger breasts for purely cosmetic reasons can get only implants filled with saline. That hasn't hurt the breast business any: More than a quarter-million women had breast-augmentation surgery last year. That's a nearly 700 percent increase since 1992, the year silicone implants were restricted for safety reasons and the first lawsuit against Dow Corning and other manufacturers was filed.

Even the bikini-unfriendly Northwest isn't immune to the lure of artificial curves. Seattle plastic surgeon Dr. Phil Haeck said his office does at least 1,000 pairs of implants per year.

Still, some women complain of sloshy results from the salt-water implants and pine for the fleshy feel of silicone gel. "This is cosmetic--patients expect perfection," Haeck said.

Enter the "cohesive" silicone gel implant, so-called because the gel is thicker. These devices, yet to be approved by the Food and Drug Administration, were the darlings of a plastic surgeon's convention recently in Vancouver, Canada, where doctors with foreheads as free of creases as their perfectly tailored suits poked, pinched and squeezed the rubber teardrops.

They see cohesive implants as the best bet in their pursuit of a better bosom, promising the feel of silicone without the fear of leaks, the flaw that brought down their predecessors.

That's yet to be proven. But despite nagging questions about health risks, some women are lining up to find out with their own bodies in clinical trials.

The appeals for more natural-looking artificial curves are why Dr. Bradley Remington, a Kirkland, Wash., plastic surgeon who does about 100 breast augmentations a year, is helping test one of the new cohesive-silicone implants, the Contour Profile Gel. He has implanted five pairs so far, and said their maker, Mentor, will release more slots for an expanded clinical trial next month. He's eagerly awaiting his new allotment so he can attend to the handful of women already on his waiting list.

Remington stands the CPG upright in his palm, showing how the implant holds its shape like a Jell-O mold, unlike the saline version, which collapses into a rubber puddle in the other hand.

"The gel is more solid, like a gummy bear--it maintains its shape and stays where it's supposed to," he said. "This is the implant of the future."

Diana Zuckerman, president of the National Center for Policy Research for Women & Families, a vocal critic of breast implants, sees the zeal for the latest implants as a case of "wishful thinking over science."

"The history of breast implants is full of `new and improveds' and riddled with failures," Zuckerman said, pointing to the polyurethane foam-coated implants in the 1980s, a so-called improvement meant to prevent scar tissue from forming. They were pulled from the market when the FDA raised concerns the foam could break down into a carcinogen.

And silicone gel is not off the hook, as far as she's concerned.

Studies have disputed the link between silicone and autoimmune diseases. In 1999, the Institute of Medicine, an independent agency that advises the government, reviewed the research and concluded that implants don't cause diseases. Zuckerman doesn't buy the report. She cites studies that suggest links to brain cancer, suicide and fibromyalgia, and notes that scientists haven't ruled out the possibility that a subset of people are allergic to silicone.

Still, the IOM report was no ringing endorsement. It warned that implants often leak and up to one-quarter of recipients need repeat surgery within five years.

Many plastic surgeons, however, think that silicone's bad rap is undeserved. "I have no reservations whatsoever about using silicone for my patients," said Dr. Mark Jewell, a Eugene, Ore., plastic surgeon and a top user of cohesive implants.

In fact, Jewell and other surgeons pressed for a return of the original silicone sacs when implantmaker Inamed sought FDA approval last fall. Most of the FDA's experts believed the implants don't cause diseases, but the agency denied approval--for now, anyway--until the company can answer what happens over time when the devices leak silicone into the body.

That's why surgeons are betting the new cohesives are the best shot to get silicone past the FDA. Early reports from doctors in the trial suggest the thicker shell and gummy-bear consistency lower the risk of ruptures and leaks.